Trial Review

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A Follow-up Study of the Efficacy of a Complementary Medicine Formulation in Primary Hypercholesterolemia

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Scientific title

A Follow-up Study to determine the efficacy and safety profile of a Pathway formulation in lowering lipid levels in primary hypercholesteremia over a 24-week period. of a Complementary Medicine Formulation in Primary Hypercholesterolemia

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Universal Trial Number (UTN)

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Trial acronym

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Linked study record

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Health condition

Health condition(s) or problem(s) studied:

Primary hypercholesteremia3440

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Condition category

Condition code

Diet and Nutrition39739700

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Other diet and nutrition disorders

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Intervention/exposure

Study type

Interventional

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Description of intervention(s) / exposure

A novel combination of plant extracts and vitamins which was delivered over 24 weeks.

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Intervention code [1]2610

Treatment: Other

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Comparator / control treatment

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Control group

Uncontrolled

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Outcomes

Primary outcome [1]4580

Changes in fasting serum low-density lipoprotein (LDL) cholesterol level from baseline to end of treatment.

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Timepoint [1]4580

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Secondary outcome [1]9920

Changes in fasting serum levels of total cholesterol

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Timepoint [1]9920

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Secondary outcome [2]9930

Changes in high-density lipoprotein cholesterol (HDL)

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Timepoint [2]9930

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Secondary outcome [3]9940

Changes in triglycerides

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Timepoint [3]9940

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Secondary outcome [4]9950

Changes in apolipoproteins B and A-1

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Timepoint [4]9950

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Secondary outcome [5]9960

Changes in coenzyme Q10 and homocysteine.

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Timepoint [5]9960

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Eligibility

Key inclusion criteria

1. LDL cholesterol ³3.5 and 5.7mmol/L 2. Body mass index 32kg/m23. Subject is willing to cease all medications over the course of the study, excluding medications for acute conditions such as pain or dyspepsia.

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Minimum age

18Years

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Maximum age

75Years

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Gender

Both males and females

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Can healthy volunteers participate?

No

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Key exclusion criteria

1. Individuals with triglyceride levels >4mmol/L2. Individuals with a total cholesterol level >10 mmol/L3. Individuals with clinically abnormal liver function tests at baseline (measured at visit 2)4. Women who are pregnant or unwilling to use birth control for the period of the study5. Individuals with diabetes6. Individuals with hyperthyroidism7. Individuals with obstructive bile duct disease8. Individuals with metabolic disorders other than primary hypercholesterolaemia, includingphytosterolaemia9. Individuals who smoke10. Individuals with cardiovascular disease11. Subjects unwilling to comply with the study protocols12. Subjects with poor venous access13. Any other condition which in the opinion of the researchers could compromise the study.

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Study design

Purpose of the study

Treatment

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Allocation to intervention

Non-randomised trial

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Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

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Masking / blinding

Open (masking not used)

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Who is / are masked / blinded?

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Intervention assignment

Single group

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Other design features

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Phase

Phase 3

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Type of endpoint(s)

Safety/efficacy

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Statistical methods / analysis

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Recruitment

Recruitment status

Completed

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Date of first participant enrolment

Anticipated

9/09/2003

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Actual

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Date of last participant enrolment

Anticipated

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Actual

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Date of last data collection

Anticipated

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Actual

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Sample size

Target

30

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Accrual to date

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Final

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Recruitment in Australia

Recruitment state(s)

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Funding & Sponsors

Funding source category [1]4490

Charities/Societies/Foundations

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Name [1]4490

Pathways

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Address [1]4490

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Country [1]4490

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Primary sponsor type

Charities/Societies/Foundations

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Name

Pathways

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Address

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Country

Australia

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Secondary sponsor category [1]3660

None

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Name [1]3660

none

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Address [1]3660

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Country [1]3660

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Ethics approval

Ethics application status

Approved

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Ethics committee name [1]14230

Southern Cross university Human research Ethics Committee

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Ethics committee address [1]14230

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Ethics committee country [1]14230

Australia

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Date submitted for ethics approval [1]14230

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Approval date [1]14230

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Ethics approval number [1]14230

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Summary

Brief summary

A follow-up study to determine the efficacy and safety profile of a natural medicine formulation in lowering lipid levels in primary hypercholesteremia over a 6-month period. The study also looked at the effect of the preparation on coenzyme Q10 levels.Study blood parameters were measured every 4 weeks